Steffen Axt1, Kristin Haller2, Peter Wilhelm2,3, Claudius Falch2,4, Peter Martus5, Jonas Johannink2, Jens Rolinger2,3, Christian Beltzer2,6, Lena Axt7, Alfred Königsrainer2, Andreas Kirschniak2,3. 1. Department of General, Visceral and Transplant Surgery, Tübingen University Hospital, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. Steffen.Axt@med.uni-tuebingen.de. 2. Department of General, Visceral and Transplant Surgery, Tübingen University Hospital, Hoppe-Seyler-Str. 3, 72076, Tübingen, Germany. 3. General and Visceral Surgery, Maria Hilf Hospital, Viersener Str. 450, 41063, Mönchengladbach, Germany. 4. General and Visceral Surgery, Vorarlberg State Hospitals, Carl-Pedenz-Str. 2, 6900, Bregenz, Austria. 5. Institute of Medical Biometry, Tübingen University Hospital, Silcherstr. 5, 72076, Tübingen, Germany. 6. Department of General, Visceral and Thoracic Surgery, Federal Armed Forces Hospital Ulm, Oberer Eselsberg 40, 89081, Ulm, Germany. 7. Department of Internal Medicine I, Hospital Reutlingen, Steinenbergstr. 31, 72764, Reutlingen, Germany.
Abstract
BACKGROUND: Reported incidence of anastomotic leakage (AL) of rectal anastomoses is up to 29% with an overall mortality up to 12%. Nevertheless, there is no uniform evidence-based diagnostic procedure for early detection of AL. The objective of this prospective clinical trial was to demonstrate the diagnostic value of early postoperative flexible endoscopy for rectal anastomosis evaluation. METHODS: Flexible endoscopy between 5 and 8th postoperative day was performed consecutively in 90 asymptomatic patients. Sample size calculation was made using the two-stage Simon design. Diagnostic value was measured by management change after endoscopic evaluation. Anastomoses were categorized according to a new classification. Study is registered in German Clinical Trials Register (DRKS00019217). RESULTS: Of the 90 anastomoses, 59 (65.6%) were unsuspicious. 20 (22.2%) were suspicious with partial fibrin plaques (n = 15), intramural hematoma and/or local blood coagulum (n = 4) and ischemic area in one. 17 of these anastomoses were treated conservatively under monitoring. In three a further endoscopic re-evaluation was performed and as consequence one patient underwent endoscopic vacuum therapy. 11 (12.2%) AL were detected. Here, two could be treated conservatively under monitoring, four with endoscopic vacuum therapy and five needed revision surgery. No intervention-related adverse events occurred. A change in postoperative management was made in 31 (34.4%) patients what caused a significant improvement of diagnosis of AL (p < 0.001). CONCLUSIONS: Early postoperative endoscopic evaluation of rectal anastomoses is a safe procedure thus allows early detection of AL. Early treatment for suspicious anastomoses or AL could be adapted to avoid severe morbidity and mortality.
BACKGROUND: Reported incidence of anastomotic leakage (AL) of rectal anastomoses is up to 29% with an overall mortality up to 12%. Nevertheless, there is no uniform evidence-based diagnostic procedure for early detection of AL. The objective of this prospective clinical trial was to demonstrate the diagnostic value of early postoperative flexible endoscopy for rectal anastomosis evaluation. METHODS: Flexible endoscopy between 5 and 8th postoperative day was performed consecutively in 90 asymptomatic patients. Sample size calculation was made using the two-stage Simon design. Diagnostic value was measured by management change after endoscopic evaluation. Anastomoses were categorized according to a new classification. Study is registered in German Clinical Trials Register (DRKS00019217). RESULTS: Of the 90 anastomoses, 59 (65.6%) were unsuspicious. 20 (22.2%) were suspicious with partial fibrin plaques (n = 15), intramural hematoma and/or local blood coagulum (n = 4) and ischemic area in one. 17 of these anastomoses were treated conservatively under monitoring. In three a further endoscopic re-evaluation was performed and as consequence one patient underwent endoscopic vacuum therapy. 11 (12.2%) AL were detected. Here, two could be treated conservatively under monitoring, four with endoscopic vacuum therapy and five needed revision surgery. No intervention-related adverse events occurred. A change in postoperative management was made in 31 (34.4%) patients what caused a significant improvement of diagnosis of AL (p < 0.001). CONCLUSIONS: Early postoperative endoscopic evaluation of rectal anastomoses is a safe procedure thus allows early detection of AL. Early treatment for suspicious anastomoses or AL could be adapted to avoid severe morbidity and mortality.
Authors: Philip Baum; Johannes Diers; Sven Lichthardt; Carolin Kastner; Nicolas Schlegel; Christoph-Thomas Germer; Armin Wiegering Journal: Dtsch Arztebl Int Date: 2019-11-01 Impact factor: 5.594